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Titles
- REMS: FDA's application of statutory factors in determining when a REMS is necessary1
- Recommendations for reducing the risk of transfusion-transmitted babesiosis1
- Recommended content and format of non-clinical bench performance testing information in premarket submissions: guidance for industry and Food and Drug Administration staff1
- Recommended statement for over-the-counter aspirin-containing drug products labeled with cardiovascular related imagery1
- Recurrent herpes labialis: developing drugs for treatment and prevention1
- Refuse to accept policy for 510(k)s: guidance for industry and Food and Drug Administration staff1
- Registration and product listing for owners and operators of domestic tobacco product establishments: (revised)1
- Regulatory classification of pharmaceutical co-crystals1
- Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use : guidance for industry and Food and Drug Administration staff1
- Requests for feedback and meetings for medical device submissions: the Q-Submission Program : guidance for industry and Food and Drug Administration staff1
- Requests for feedback on medical device submissions: the pre-submission program and meetings with Food and Drug Administration staff : guidance for industry and Food and Drug Administration staff1
- Requirements for transactions with first responders under section 582 of the Federal Food, Drug, and Cosmetic Act--compliance policy1
- Revised recommendations for reducing the risk of Zika virus transmission by blood and blood components1
- Risk evaluation and mitigation strategies: modifications and revisions1